Over 140,000 bottles of a prescription statin have been recalled due to "failed dissolution specifications," according to a U.S. Food and Drug Administration (FDA) enforcement report.
Ascend Laboratories of New Jersey pulled Atorvastatin Calcium, a drug sold as a generic version of Lipitor, that were manufactured by Alkem Laboratories of India and distributed nationwide. The recall, issued on Sept. 19, covers tablets packaged in 90-count, 500-count and 1,000-count bottles with expiration dates as late as February 2027.
On Oct. 10, the FDA classified the recalled prescription medication as a Class II recall. The risk classification from the federal agency indicates that the recalled medications could cause "temporary or medically reversible adverse health consequences," but that the chances of serious adverse health consequences are "remote."
Statins are the drugs of choice in treating high cholesterol and preventing or reducing heart disease, according to a 2023 study from Florida Agricultural and Mechanical University.
Dr. Tamanna Singh of the Cleveland Clinic said "about 39 million adult Americans" are on statins, with the largest demographic taking the medication being over 40 years old, on a podcast for the clinic in September. She added that Lipitor, Crestor and their generics, atorvastatin and rosuvastatin, respectively, are the most commonly prescribed statins.
